510(k) Report

510(k) · Cleared

Cleared

M1350A Fetal Monitor (Intrapartum)

K900480510(k) TraditionalCleared Jul 2, 1990151-day reviewClass II21 CFR 884.2740

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hewlett-Packard Co. · HGM System, Monitoring, Perinatal

Cleared on Jul 2, 1990 after a 151-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 117 later devices descend from it.

Decided
Jul 2, 1990
Review
151 days
Class
Class II
Product code
HGM
Recalls
None
Predicates
0

117 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 1996: 2 descendants cleared2012: 2 descendants cleared2006: 3 descendants cleared2003: 2 descendants cleared2002: 1 descendant cleared2000: 1 descendant cleared2014: 6 descendants cleared2011: 6 descendants cleared2017: 6 descendants cleared2015: 5 descendants cleared2010: 4 descendants cleared2005: 4 descendants cleared2013: 2 descendants cleared1999: 1 descendant cleared2004: 1 descendant cleared2007: 2 descendants cleared2016: 2 descendants cleared2018: 5 descendants cleared2023: 8 descendants cleared2008: 1 descendant cleared2024: 9 descendants cleared2020: 6 descendants cleared2022: 13 descendants cleared2026: 8 descendants cleared2025: 9 descendants cleared2021: 6 descendants cleared2019: 2 descendants cleared1990200020102020
  1. This deviceK900480 M1350A Fetal Monitor (Intrapartum)Hewlett-Packard Co. · 1990
  2. Descendant · cites it directly · 98 of its ownK954351 Series 50XMHewlett-Packard GmbH · 1996
  3. Descendant · cites it directly · 76 of its ownK023931 Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A…Philips Medical Systems, Inc. · 2003
  4. Descendant · 2 generations on · 64 of its ownK100598 Penrith Elettra Ultrasound SystemPenrith Corporation · 2010
  5. Descendant · 3 generations on · 33 of its ownK151339 SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd. · 2015
  6. Descendant · 3 generations on · 29 of its ownK162417 Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2016

Showing 5 of 117 descendants. See all descendants

Descendants cleared per year

1996: 21999: 12000: 12002: 12003: 22004: 12005: 42006: 32007: 22008: 12010: 42011: 62012: 22013: 22014: 62015: 52016: 22017: 62018: 52019: 22020: 62021: 62022: 132023: 82024: 92025: 92026: 8
1996high 13 (2022) · low 0 (1997)2026

Most influential descendants

Showing 5 of 117 · See all
  • K954351Series 50XMHewlett-Packard GmbH · 1996 · cites it directly98descendants
  • K023931Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A, M2726A, M2727APhilips Medical Systems, Inc. · 2003 · cites it directly76descendants
  • K100598Penrith Elettra Ultrasound SystemPenrith Corporation · 2010 · 2 generations on64descendants
  • K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd. · 2015 · 3 generations on33descendants
  • K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2016 · 3 generations on29descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K900480M1350A Fetal Monitor (Intrapartum)Hewlett-Packard Co.1990—
+1K954351Series 50XMHewlett-Packard GmbH1996—
+1K023931Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A…Philips Medical Systems, Inc.2003—
+2K100598Penrith Elettra Ultrasound SystemPenrith Corporation2010—
+3K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd.2015—
+3K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
199910
200010
200210
200320
200410
200540
200630
200720
200810
201040
201160
201220
201320
201460
201550
201620
201760
201850
201920
202060
202160
2022130
202380
202490
202590
202680
FIG. 1 — Lineage of K900480, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HGM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HGM device

  1. #1 K241882 Fetal & Maternal Monitor (F15A, F15A Air)score 19.5 · 33 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (117)

See all 117

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K954351Series 50XMHewlett-Packard GmbH199698
K023931Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A, M2726A, M2727APhilips Medical Systems, Inc.200376
K955559Corometrics Fetal Movement Detection KitGe Medical Systems Information Technologies199611
K013477Toco Lite, Model TD-01Ventrex, Inc.20025
K992811Transducers for Ultrasound and Tocodynamometer Fetal MonitoringEpic Medical Equipment Services, Inc.20002
K120018Mindchild Meridian Fetal Heart Rate MonitorMindchild Medical20121
K050826Fetal Ultrasound and Tocodynamometer TransducersCetro America20060

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K954351 (Hewlett-Packard GmbH, 1996) has gone furthest, with 98 descendants of its own.

How does its category compare?

All HGM devices

HGM System, Monitoring, Perinatal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HGM

4in 2025

2007: 32008: 42009: 42010: 42011: 132012: 42013: 22014: 42015: 52016: 12017: 32018: 32020: 12022: 12023: 22024: 12025: 42026 (partial year): 2
2007high 13 (2011) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HGM

269in 2025

2007: 56 days median2008: 75 days median2009: 66 days median2010: 193 days median2011: 141 days median2012: 107 days median2014: 231 days median2015: 169 days median2017: 138 days median2018: 258 days median2025: 269 days median
2007high 269 (2025) · low 56 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HGM

5in 2019

2008: 42009: 62013: 12014: 12019: 52026 (partial year): 2
2007high 6 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HGM

99in 2025

2007: 352008: 172009: 422010: 642011: 832012: 442013: 162014: 302015: 442016: 172017: 272018: 302019: 412020: 192021: 712022: 872023: 692024: 1742025: 99
2007high 174 (2024) · low 16 (2013)2025

MAUDE reports naming product code HGM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007356035
2008475417
2009466642
20104193064
201113141083
20124107044
20132—116
20144231130
20155169044
20161—017
20173138027
20183258030
20190—541
20201—019
20210—071
20221—087
20232—069
20241—0174
20254269099
20262—2—

More from Hewlett-Packard Co.

230 FDA decisions under this applicant name. See the company

  • K992543Heartstream XLT Defibrillator/Monitor, AC Charger, DC Charger, Data Card, Single Bay Adapter, Defibrillator…Hewlett-Packard Co. · 2000
  • K993587HP M2376A Device Link SystemHewlett-Packard Co. · 2000
  • K993169Modification of: Physiological Signal Transmitter and Receiver, Model 3810AHewlett-Packard Co. · 1999
  • K992977Hewlett Packard Multifunction Pediatric Defib Function, Model M3503A & M3504AHewlett-Packard Co. · 1999
  • K993516HP M2600A Viridia Telemetry SystemHewlett-Packard Co. · 1999

Recent decisions in HGM

The HGM category page

  • K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc. · 2026
  • K253021ANNE MaternalSibel Health, Inc. · 2026
  • K250777Sonicaid Team3Huntleigh Healthcare, Ltd. · 2025
  • K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc. · 2025
  • K241368Sonicaid Team3Huntleigh Healthcare, Ltd. · 2025

https://510kreport.com/device/K900480 · printed Nov 6, 2026

Cite this page

510(k) Report. “K900480: M1350A Fetal Monitor (Intrapartum).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900480

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026